04/05/2015

FDA's eIC Draft Guidance: this guidance was released on heels of the FDA Draft Informed Consent Information Sheet. This latest IC guidance is specific to electronic media use for informed consent and process of consent implications. The guidance is in Q&A format and OHRP posted a question to their audience whether the FDA Guidance should be a guidance from both FDA and OHRP.

There is only a 60 day comment period for both the FDA draft guidance and the OHRP's question regarding the collaboration. This guidance was prepared by Center for Drug Evaluation and Research (CDER) and the Office of Good Clinical Practice (OGCP) in coordination with the Center for Biologics Evaluation Research (CBER) and the Center for Devices and Radiological Health (CDRH). This guidance document was developed in consultation with the Department of Health and Human Services’ Office of Human Research Protections (OHRP).

In 9 short pages the draft covers 13 questions about use of eICs related to the information presented to the subject, processes used for obtaining informed consent, and documentation of the electronic informed consent (eIC) must meet the requirements of these and other applicable regulations.

Take a look and what do you see as good and unclear points. Post here. Thanks!